NCT03413527Unknown2 期
Examining the Impact of Transcranial Magnetic Stimulation (rTMS) on Schizophrenia and Related Disorders: A Case Series
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Positive and Negative Symptom Scale (PANSS)
研究概览
简要总结
This study will examine the effects of rTMS on the negative and positive symptoms of schizophrenia using 2 treatments in sequence applied to related brain areas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •are voluntary and competent to consent to treatment
- •have a diagnosis of schizophrenia or schizoaffective disorder
- •are between the ages of 18 and 75
- •are willing and able to adhere to the treatment schedule
- •Pass the TMS adult safety-screening (TASS) questionnaire
- •have normal thyroid functioning based on pre-study blood work. Patients may be reassessed for the study once thyroid levels have normalized.
- •are willing and able to cooperate with interviews and follow simple instructions
排除标准
- •do not pass the TASS Safety Screening Questionnaire
- •have a significant history of seizures
- •have active suicidal intent
- •are pregnant or may be pregnant. A pregnancy test will be performed for fertile women.
- •have failed a course of Electroconvulsive Therapy (ECT) in the current or previous episode
- •have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure except those therapeutically induced by ECT, cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis, or head trauma resulting in loss of consciousness greater than or equal to 5 minutes
- •have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed
- •have had changes in dose or initiation of any psychotropic medication in the 4 weeks prior to screening. Patients may be re-screened once medications have been stable for 4 weeks.
- •currently (or in the last 4 weeks) take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy
研究组 & 干预措施
rTMS Treatment
Experimental
干预措施: rTMS (Device)
结局指标
主要结局
Positive and Negative Symptom Scale (PANSS)
时间窗: Change from pre-treatment to post treatment over 6 weeks
semi-structured interview designed to rate the severity of schizophrenia symptoms. Score from 0-231, with higher score being worse.
次要结局
- Hamilton Depression Rating Scale (HAM-D)(change from pre-treatment to post treatment over 6 weeks)
- Beck Depression Inventory(Change from pre-treatment to post treatment over 6 weeks)
研究者
Gary Chaimowitz
Principal Investigator, Head of Forensics Service
St. Joseph's Healthcare Hamilton
研究点 (2)
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